Sepsis Limited

Spectral Diagnostics, Inc.

Alexander D Romaschin

Paul M Walker

The invention relates to a method for measuring the level of a preselected analyte in a sample of blood of a human or animal patient by incubating the test sample with an antibody specific to the analyte to form an immunocomplex, which then interacts with the white blood cell fractions and result in the production of oxidants. Oxidants are detected using chemiluminescent reagents. The assay is performed on the sample and in addition includes a measurement of the oxidant production resulting from a maximal stimulatory dose of immunocomplexes, providing a ratio to indicate the level of analyte in the sample. The white blood cell oxidant response may be enhanced by the inclusion of certain agents such as zymosan. This method may be used to determine levels of analytes in a sample of a patient's blood including endotoxin and other analytes related to sepsis, in order to select the proper therapeutic course, or may be used to measure other analytes such as inflammatory mediators, hormones, acute phase proteins, toxins, drugs of abuse, markers of cardiac muscle damage, therapeutic drugs, cytokines, and chemokines. Additional parameters derived from the assay include maximal chemiluminscent response and responsiveness to aid in the staging of sepsis.

Measurement of analytes in whole blood

The invention relates to a method for quantitating the level of a preselected analyte in a sample of blood of a human or animal patient by incubating the test sample with an antibody specific to the analyte to form an immunocomplex, which then interacts with the white blood cell fractions and result in the production of oxidants. Oxidants are detected using chemiluminescent reagents. In addition, the white blood cell oxidant response may be enhanced by the inclusion of certain agents such as opsonized zymosan. As part of the assay, separate blood samples are also maximally stimulated with a maximal stimulatory amount of exogenously-added antigen, and corresponding antibody, to form immunocomplexes, to provide a response factor used in the quantitation of analyte. This quantitative method may be used to determine levels of analytes in a sample of a patient's blood including endotoxin and other analytes related to sepsis, in order to select the proper therapeutic course, or may be used to measure other analytes such as inflammatory mediators, hormones, acute phase proteins, toxins, drugs of abuse, markers of cardiac muscle damage, therapeutic drugs, cytokines, and chemokines.

Quantitation of analytes in whole blood

The invention relates to a method for staging sepsis in a patient by concurrently measuring in a sample of the patient's blood four parameters which are indicative of the stage of sepsis: 1) the level of microbial product level in the blood; 2) the level of tumor necrosis factor (TNF) response reserve; 3) the maximum oxidant production by neutrophils, and 4) the responsiveness of the patient's neutrophils to immunocomplexes. Based on determining the stage of sepsis, appropriate treatment for the patient may be identified.

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Etobicoke, Canada

Alexander D Romaschin